Recall Z-1731-2009 ยท MMI Immunoassay Method, Troponin Subunit
Siemens Healthcare Diagnostics, Inc.
Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute
| Date | Aug 12, 2009 (initiated Apr 8, 2008) |
| Status | Terminated |
| Reason | possibility of falsely elevated results |
| Root cause | Process control |
| Action | Siemens Healthcare Diagnostics issued a letter to their customers starting April 8, 2008 informing them of the problem and to discontinue use of the product. Further questions should be addressed to Siemens Healthcare Diagnostics, Inc. at 1-800-441-9250. |
| Quantity | 4,574 cartons |
| Distribution | Worldwide Distribution -- Including countries of the United States, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010313 | DIMENSION CTNI FLEX REAGENT CARTRIDGE Dade Behring, Inc., Apr 20, 2001 |